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Completed

NCT Number: NCT00357643

Effect of Calcium and Vitamin D on Bone Loss From the Hip

The primary aim of this study is to determine the effects of supplementation with both calcium and vitamin D on changes in bone density of the hip in men and women age 65 and older.

Completed

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Human Nutrition Research Center on Aging at Tufts U

Boston, Massachusetts, 02111, United States

About this study

In this study 445 men and women age 65 and older were enrolled for three years each. Subjects were randomized to treatment with 500 mg of calcium s calcium citrate malate plus 700 IU of vitamin D daily or placebo. Subjects came to the research center every six months for biochemical and bone mineral density measurements. Changes in these measures over the three years were determined in each group and compared.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

>65 years calcium intake < 1500 mg/day Willing to discontinue calcium and vitamin D pills for 2 months prior to enrollment

Exclusion criteria

Mentally incompetent, femoral neck BMD greater than 2 SD above/below age/sex-matched reference mean, 24-hr urine calcium/creatinine > 300 mg/d women or >350 mg/d men terminal illness, renal disease requiring treatment, kidney stone in the past 10 years, current hyperparathyroidism, treated with glucocorticoids, estrogen or androgen, fluoride, calcitonin, bisphosphonate, or any other treatment for osteoporosis.

Treatment and study plan

Calcium 500 mg/day and vitamin D 700 IU/day

Drug

Primary outcomes

  1. Bone Density of the hip

Secondary outcomes

  1. Annual and Seasonal patterns of change in bone mineral density of the hip

  2. Associations between biochemical, physical and life-style factors

  3. Examine influence of clinical status, lifestyle, medication use and season on the occurrence of falls

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
1992
Study completion
1996
First posted
Jul 27, 2006
Registry last updated
Jul 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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